FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
134113–134136 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 20, 1988
JOHNSON & JOHNSON MODULAR TOTAL KNEE PROSTHESIS
K882234 · JWH
Johnson & Johnson Professionals, Inc.
Orthopedic · 146d
Cleared Oct 20, 1988
KISS OF MINT(TM) NON-LUBRICATED CONDOM
K882389 · HIS
Ansell, Inc.
Obstetrics & Gynecology · 132d
Cleared Oct 20, 1988
SAMUELSON SCREWLOC CUP
K882671 · KWA
Protek, Inc.
Orthopedic · 114d
Cleared Oct 20, 1988
EXTRAVAKIT FOR RADIOLOGICAL APPLICATIONS
K883220 · FMF
Cancer Technologies, Inc.
General Hospital · 83d
Cleared Oct 20, 1988
CODMAN NEUROLASE LASER SYSTEM
K883642 · GEX
I.L. Med, Inc.
General & Plastic Surgery · 58d
Cleared Oct 20, 1988
TDX AMPHETAMINE/METHAMPHETAMINE II
K883707 · DKZ
Abbott Laboratories
Chemistry · 51d
Cleared Oct 20, 1988
BASE, DENTURE, RELINING, REPAIRING, REBASING,RESIN
K883799 · EBI
Austenal Dental, Inc.
Dental · 43d
Cleared Oct 20, 1988
BALLET STERILE DISPOSABLE ELECTROLYSIS
K883892 · KCW
Synoptic Products
General & Plastic Surgery · 36d
Cleared Oct 20, 1988
TANGENT II
K883974 · IZZ
Fischer Imaging Corp.
Radiology · 30d
Cleared Oct 19, 1988
KONTRON PULSE OXIMETER 7840
K873624 · DQA
Kontron Instruments, Inc.
Anesthesiology · 407d
Cleared Oct 19, 1988
CHANGES TO ENCOR PERVENOUS J-ATRIAL LEADS
K873772 · DTB
Cordis Leads, Inc.
Cardiovascular · 399d
Cleared Oct 19, 1988
TCT-300S COMPUTED TOMO. (CT) X-RAY SYSTEM FOR EXAM
K881305 · JAK
Toshiba Medical Systems
Radiology · 205d
Cleared Oct 19, 1988
WILSON BIOMEDICAL CORONARY GUIDING CATHETER
K881793 · DQY
Wilson Biomedical, Inc.
Cardiovascular · 176d
Cleared Oct 19, 1988
PULSED FLUOROSCOPIC CONTROL MODEL:PF-02
K882358 · IZI
U.S. Imaging, Inc.
Radiology · 134d
Cleared Oct 19, 1988
STAR ALLOYS, LITE ALLOYS AND BRITE ALLOYS
K882532 · EJT
Five Stars Alloys , Ltd.
Dental · 120d
Cleared Oct 19, 1988
VISIO-PERL
K882566 · EBF
Espe GmbH (Us)
Dental · 119d
Cleared Oct 19, 1988
NICOLET BRAINLAB SYSTEM
K882599 · GWK
Nicolet Instrument Corp.
Neurology · 117d
Cleared Oct 19, 1988
NORMOCAP 200 CAPNOMETER
K882748 · CCK
Datex Division Instrumentarium Corp.
Anesthesiology · 106d
Cleared Oct 19, 1988
DATEX AIRWAY MONITOR
K882885 · CCK
Datex Division Instrumentarium Corp.
Anesthesiology · 100d
Cleared Oct 19, 1988
OHMEDA CONTINUOUS SUCTION REGULATOR
K883229 · KDP
Ohmeda Medical
General Hospital · 79d
Cleared Oct 19, 1988
VISTA MR 2055 HP SYSTEM
K883482 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 64d
Cleared Oct 19, 1988
FAST AND CE-FAST MRI SEQUENCES (FOR NMR 1000)
K883519 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 62d
Cleared Oct 19, 1988
OXOID INFECTIOUS MONONUCLEOSIS KIT
K883540 · KTN
Unipath , Ltd.
Immunology · 62d
Cleared Oct 19, 1988
BETA 3000M MOBILE NMR IMAGING SYSTEM
K883648 · LNH
Fonar Corp.
Radiology · 50d